The primary objective of this study is to assess the efficacy of Glycopyrrolate/Formoterol Fumarate MDI relative to individual components (GP MDI and FF MDI) in subjects with moderate to severe COPD
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
159
Pearl Investigative Site
Glendale, Arizona, United States
Pearl Investigative Site
Rancho Mirage, California, United States
FEV1 AUC 0-12 on Day 7
FEV1 AUC 0-12
Time frame: Day 7
Peak Change From Baseline in FEV1 on Treatment Day 1
Peak change from Baseline in FEV1 on Treatment
Time frame: Day 1
Time to Onset of Action (>10% Improvement in FEV1) on Day 1
Time to onset of action (\>10% improvement in FEV1)
Time frame: Day 1
Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1
Proportion of subjects achieving \>=12% improvement in FEV1
Time frame: Day 1
Peak Change From Baseline in Inspiratory Capacity on Day 1
Peak change from baseline in Inspiratory Capacity
Time frame: Day 1
Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7
Change from baseline in morning pre-dose trough FEV1
Time frame: Day 7
Peak Change From Baseline in FEV1 on Day 7
Peak change from baseline in FEV1 Day 7
Time frame: Day 7
Change From Baseline in Morning Pre-dose Trough IC on Day 7
Change from baseline in morning pre-dose trough IC
Time frame: Day 7
Peak Change From Baseline IC on Day 7
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Taken as 1 capsule containing 18 µg of Tiotropium via the Handihaler DPI for 7 days
Pearl Investigative Site
Waterbury, Connecticut, United States
Pearl Investigative Site
Clearwater, Florida, United States
Pearl Investigative Site
Clearwater, Florida, United States
Pearl Investigative Site
Pensacola, Florida, United States
Pearl Investigative Site
Winter Park, Florida, United States
Pearl Investigative Site
Lafayette, Louisiana, United States
Pearl Investigative Site
North Dartmouth, Massachusetts, United States
Pearl Investigative Site
Fridley, Minnesota, United States
...and 9 more locations
Peak change from baseline IC
Time frame: Day 7
Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7
Change from baseline at evening 12-hour post-dose trough FEV1
Time frame: Day 7
Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7
Change from baseline in mean morning pre-dose daily peak flow readings
Time frame: Day 7
Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7
Change from baseline in mean morning post-dose daily peak flow readings on
Time frame: Day 7
Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7
Change from baseline in mean evening pre-dose daily peak flow readings (BID treatments only)
Time frame: Day 7
Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7
Change from baseline in mean evening post-dose daily peak flow readings (12 Hours post-dose for Spiriva)
Time frame: Day 7